Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
75721–75744 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 11, 2002
ACETAMINOPHEN ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
K020792 · LDP
Bayer Diagnostics Corp.
Toxicology · 122d
Cleared Jul 11, 2002
SALICYLATE ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
K020794 · DKJ
Bayer Diagnostics Corp.
Toxicology · 122d
Cleared Jul 11, 2002
NO-POKES NEEDLE SAFETY DEVICE
K020921 · FMI
Bemis Mfg. Co.
General Hospital · 112d
Cleared Jul 11, 2002
ILT TORQUER, MODEL 114TR1
K021243 · DQX
Intra Luminal Therapeutics, Inc.
Cardiovascular · 83d
Cleared Jul 11, 2002
MONARCH SPINE SYSTEM
K021335 · MNH
Depuyacromed
Orthopedic · 76d
Cleared Jul 11, 2002
DELIGHT DENTAL ER: YAG LASER SYSTEM
K021616 · GEX
Continuum Electro-Optics, Inc.
General & Plastic Surgery · 56d
Cleared Jul 11, 2002
AARON A950 HIGH FREQUENCY ELECTROSURGICAL GENERATOR, AARON A950...
K021817 · GEI
Aaron Medical Industries
General & Plastic Surgery · 38d
Cleared Jul 11, 2002
CRPEX-HS CRP CALIBRATOR SET, CATALOG NO: 1510
K021882 · DCN
Good Biotech Corp.
Immunology · 34d
Cleared Jul 11, 2002
DOLPHIN MEDICAL STAND-ALONE PULSE OXIMETER, MODEL 2100
K021959 · DQA
Dolphin Medical, Inc.
Anesthesiology · 27d
Cleared Jul 11, 2002
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH ALOE VERA, GREEN COLOR
K022087 · LYZ
Shanghai PT Plastics Enterprise...
General Hospital · 14d
Cleared Jul 10, 2002
ALOKA SSD-1000 DIAGNOSTIC ULTRASOUND SYSTEM, MODELS ASU-1003, UST-9121, UST-9124
K020668 · IYO
Aloka Co., Ltd.
Radiology · 131d
Cleared Jul 10, 2002
MICHEALTH ET 1100/ET 1200 INFARED EAR THERMOMETER
K021601 · FLL
Duteck Industrial Co., Ltd.
General Hospital · 56d
Cleared Jul 10, 2002
CONCENTRIC BALLOON GUIDE CATHETER, MODEL 90072
K021899 · DQY
Concentric Medical, Inc.
Cardiovascular · 30d
Cleared Jul 10, 2002
KODAK X-OMAT CASSETTE/LEADLESS FOR DENTAL USE
K021903 · IXA
Eastman Kodak Company
Radiology · 30d
Cleared Jul 09, 2002
AM-BIO EXTENDED RANGE SERIES DIALYZER, MODELS WET AND DRY
K013418 · KDI
Asahi Medical Co., Ltd.
Gastroenterology & Urology · 267d
Cleared Jul 09, 2002
VP-2000/1000
K013434 · DXN
Colin Corp.
Cardiovascular · 266d
Cleared Jul 09, 2002
BIOTEQUE 3 IN 1 HEMODIALYSIS BLOOD TUBING PACK
K013634 · FJK
Bioteque Corp.
Gastroenterology & Urology · 246d
Cleared Jul 09, 2002
ENDOVIVE INITIAL PLACEMENT GASTROSTOMY KIT
K014297 · KNT
Boston Scientific Corp
Gastroenterology & Urology · 190d
Cleared Jul 09, 2002
EASI 12 LEAD ALGORITHM
K020456 · DRW
Philips Medical Systems
Cardiovascular · 148d
Cleared Jul 09, 2002
HORIZON PHACOEMULSIFICATION SYSTEM, MODEL HZN-2030
K020527 · HQC
American Optisurgical, Inc.
Ophthalmic · 140d
Cleared Jul 09, 2002
AURORA DS
K021149 · GEX
Syneron Medical, Ltd.
General & Plastic Surgery · 90d
Cleared Jul 09, 2002
TSRH SPINAL SYSTEM
K021170 · KWP
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 88d
Cleared Jul 09, 2002
STARLIGHT
K021207 · OAN
Orthomerica Products, Inc.
Neurology · 84d
Cleared Jul 09, 2002
DIAMEDIX IS-RHEUMATOID FACTOR TEST SYSTEM
K021394 · DHR
Diamedix Corp.
Immunology · 68d